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Completed

NCT Number: NCT06320171

Efectivity of Non-invasive Neuromodulation in Parasympathic Nervous System and Vascular System

The aim of the present study is to evaluate the acute effect immediately after the application of the NESA treatment in healthy participants in vascular sonographic variables measured in the left CCA such as the LD, IMT and PSV, as well as systolic (sBP) and diastolic blood (dBP) pressure and heart rate (HR). The investigators hypothesized that NESA application will induce a direct influence in the vascular tone through the stimulation of the ANS and the parasympathetic nerve system. This premise is based on the fact that non-invasive NESA neuromodulation enhance the autonomic regulation of vascular tone and endothelial function.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Europea de Madrod

Villaviciosa de Odón, Spain

About this study

The aim of the present study is to evaluate the acute effect immediately after the application of the NESA treatment in healthy participants in vascular sonographic variables measured in the left CCA such as the LD, IMT and PSV, as well as systolic (sBP) and diastolic blood (dBP) pressure and heart rate (HR). We hypothesize that NESA application will induce a direct influence in the vascular tone through the stimulation of the ANS and the parasympathetic nerve system. This premise is based on the fact that non-invasive NESA neuromodulation enhance the autonomic regulation of vascular tone and endothelial function.A total sample of forty participants (N = 40; mean age 26.6 ± 6.7 years) were recruited for participation in the study. Prior to entering the study, all participants received information about the study and signed a consent form to participate. The study subjects were divided into two equally distributed groups (A: NESA = 20; B: Placebo = 20) and were blinded to the study group allocation. Participants in the placebo group underwent the same procedural phases as those in the intervention group. However, for the placebo group, the device was set to deliver a low-intensity current below the sensory threshold, effectively rendering it inactive from the participants' perspective.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • Age between: 18-55 years, both sexes.

Exclusion:

  • Cardiovascular disease.
  • Specific pharmacology.
  • Hypertension.
  • Diabetes.
  • Systemic diseases.

Treatment and study plan

Non-invasive Neuromodulation

Device

Direct stimulation of the autonomic nervous system was achieved using Program 7 (P7) of the device, with a directional electrode positioned at the level of the C7 spinous process. P7 delivered a biphasic polarity current with oscillatory frequencies ranging from 1.92 to 14.29 Hz and variable intensities between 0.1 and 0.9 mA.

Placebo

Other

The placebo group followed the same procedure, except that no current was applied during their 20-minute session.

Primary outcomes

  1. Systolic and diastolic Blood Pressure:

    Time frame: before the intervention, and 10 minutes after the intervention

    The pressure in the arteries during the contraction of the heart muscle. Measured with sphingomanometer.

  2. Heart rate

    Time frame: Before the intervention, and 10 minutes after the intervention

    Hearbears per minute

Secondary outcomes

  1. Ultrasonographic variables: Cross-sectional area of the jugular vein

    Time frame: Before the intervention, and 10 minutes after the intervention

    Cross-sectional area of the jugular vein

  2. Ultrasonographic variables:Cross-sectional area of the common carotid

    Time frame: Before the intervention, and 10 minutes after the intervention

    Cross-sectional area of the common carotid

  3. Ultrasonographic variables:Thickness of the common carotid

    Time frame: Before the intervention, and 10 minutes after the intervention

    Thickness of the common carotid

  4. Ultrasonographic variables:Peak systolic velocity.

    Time frame: Before the intervention, and 10 minutes after the intervention

    Peak systolic velocity.

  5. Cortisol measurement

    Time frame: Before the intervention, and 10 minutes after the intervention

    Measure of cortisol level.

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2024
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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